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Re: Echo20 post# 75090

Friday, 10/11/2013 11:12:11 AM

Friday, October 11, 2013 11:12:11 AM

Post# of 146248

Now maybe some news on TOX, MERS, H7N9.




In vivo non-GLP and GLP toxicology


In vivo toxicology has central role in assessing the toxicology profile of for example developed drug compounds, manufactured chemicals, novel food ingredients. Understanding and experience in in vivo toxicology experiments, knowledge on possible alternative testing strategies and knowing the various regulatory authorities is needed to plan and conduct toxicological assessments.

In vivo toxicology can be done in both under accredited GLP (Good Laboratory Practice) settings as well as in early non-GLP settings. Non-GP experiments are faster to conduct and less expensive, whilst regulatory toxicology and safety studies conducted under the GLP settings are needed in e.g. drug discovery/preclinical and clinical development, novel functional food ingredient and REACH chemical safety testing.

The goals of the nonclinical safety evaluation include: A characterization of toxic effects with respect to target organs, dose dependence, relationship to exposure, and potential reversibility. This information is important for the estimation of an initial safe starting dose for the human trials and the identification of parameters for clinical monitoring for potential adverse effects.

Tox Screen early non-GLP toxicology

Tox Screen is a service for screening lead series or different dose levels based on their in vivo toxicological properties in rodents. This service has been designed to yield data that allow elimination of unsuitable compounds early at the discovery stage and also to provide input for planning regulatory toxicological studies.

Look like we will have the tox results very quickly!

FN
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